111 medicines fail quality test, regulatory body CDSCO issues market alert
The Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare conducts monthly sample tests from sales or distribution points to prepare a list of spurious or poor-quality drugs.
The Central Drugs Standard Control Organisation (CDSCO) has found a total of 111 drug samples in November as 'not of standard quality' (NSQ). Among 111 drugs, 41 were tested in the Central laboratory while 70 drugs were tested in state laboratories.
It must be noted that the identification of drug samples as NSQ is done based on the failure of the drug sample in one or the other specified quality parameters. "The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market," an official said.
As part of continuous regulatory surveillance, the CDSCO picks drug samples from sales/distribution points and analyzes them. Subsequently, a list of Not of Standard Quality (NSQ) drugs is displayed on the CDSCO portal every month. The current list of NSQ drugs is from the samples tested in November.
According to the CDSCO, the purpose of displaying the NSQ list is to make stakeholders aware of the NSQ batches identified in the market. Notably, the list comprises the drug composition, date of manufacturing, and expiry along with the name of the manufacturer and the test which it failed.
List of NSQs tested in Centre laboratory
List of NSQs tested in State laboratories
Two drugs found spurious
Meanwhile, two drug samples were also identified as spurious drugs in November. Out of the two samples, one was picked by Bihar Drugs Control Authority and the other by CDSCO, Ghaziabad, the sources said. The drugs were made by unauthorised and unknown manufacturers, using brand names of other companies.
These drugs include Pantoprazole Gastro-Resistant Tablets I.P.( PAN-40) with Batrch number 23443074 and Amoxycillin and Potassium Clavulanate Tablets IP (AUGMENTIN625 DUO) with Batch number 824D054.
(With PTI Inputs)